Job Description
A data reviewer is required to support batch release and stability programs.
Key Responsibilities of this position
* Review data in a timely manner to ensure compliance with quality standards.
* Experience with Empower is essential for trending and analyzing results.
* Check results against specifications and identify deviations or lab investigations.
* Track and identify not right first time (NRFTs) events and implement corrective actions.
* Support the laboratory team and management in ensuring quality and compliance.
* Interact with other departments on matters related to raw materials, intermediates and finished batch releases.
* Maintain, update and issue control prints, methods, specifications and SOP's in compliance to pharmacopeial requirements.
* Assist with training of analysts in areas of expertise and knowledge and in new methods, SOP's and updates.
Required Skills and Qualifications
* Excellent communication and interpersonal skills.
* Initiative and ability to work independently to see issues through to completion.
* Ability to prioritize workload and meet deadlines.
* Extensive knowledge of cGMP and GDP in a regulated environment.
* Working knowledge of quality systems in a regulated environment.
* Excellent accuracy and attention to detail.
Benefits of this role
This is a 12-month contract opportunity to work with our pharmaceutical client in Waterford.
Why you should apply
If you are a detail-oriented and proactive individual with excellent communication skills, we encourage you to apply for this role.